Gallbladder Cryoablation in High-Risk Patients

NCT04915651 | Unknown DMC FDA Device

• 1 other identifier: 1904567382
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Benign gallbladder disease, including acute cholecystitis, chronic cholecystitis, biliary dyskinesia, and biliary colic, is very common, with over 300,000 surgical cholecystectomies performed per year in the US. Unfortunately, complication rates in elderly patients or patients with many comorbidities are high. These patients are often managed with percutaneous tube drainage of the gallbladder (percutaneous cholecystostomy). The recurrence rate of calculous cholecystitis after cholecystostomy tube removal is as high as 35% at 1 year. These patients are thus faced with permanent cholecystostomy tube drainage, high-risk surgery, or cholecystostomy tube removal and risk of repeat cholecystitis. Gallbladder cryoablation is an alternative to surgical cholecystectomy which is performed percutaneously and does not require general anesthesia. Published evidence on the outcomes of gallbladder cryoablation is however limited at this point in time. The purpose of the proposed study is to follow the outcomes of high-risk patients who undergo gallbladder cryoablation.

Conditions

Gallbladder Diseases; Cholecystitis; Biliary Colic; Gallstone; Cholecystitis; Biliary Dyskinesia; Gallstone; Gall Bladder Pain

Keywords

cryoablation; gallstones; gallbladder; cholecystitis

Outcome Measures

Primary Outcomes (2)

• Symptomatic relief

  Absence of right upper quadrant abdominal pain and nausea and absence of repeat episodes of cholecystitis, which would manifest as right upper quadrant abdominal pain associated with a fever (\>100 C) and leukocytosis.

  Up to 2 years after procedure

• Complications

  Clavien-Dindo classification complications

  Up to 2 years after procedure

Secondary Outcomes (1)

• Imaging

  Up to 2 years after procedure

Study Arms (1)

Gallbladder Cryoablation

EXPERIMENTAL

High-risk patients who undergo gallbladder cryoablation

Device: Gallbladder Cryoablation

Interventions

Gallbladder Cryoablation DEVICE

Percutaneous cryoablation of the gallbladder.

Gallbladder Cryoablation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Patients with benign gallbladder disease who are eligible for surgical cholecystectomy or who are unable to provide informed consent.

Sponsors & Collaborators

• University of Arizona: lead

Study Sites (1)

University of Arizona

Tucson, Arizona, 85724, United States

RECRUITING

MeSH Terms

Conditions

Gallbladder Diseases; Cholecystitis; Acalculous Cholecystitis; Biliary Dyskinesia; Gallstones

Condition Hierarchy (Ancestors)

Biliary Tract Diseases; Digestive System Diseases; Common Bile Duct Diseases; Bile Duct Diseases; Cholelithiasis; Cholecystolithiasis; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Hugh McGregor, MD

  University of Arizona

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hugh McGregor, MD

CONTACT

520-626-1069; hughcjmcgregor@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 28, 2021
• First Posted: June 7, 2021
• Study Start: July 1, 2021
• Primary Completion: July 1, 2022
• Study Completion: July 1, 2023
• Last Updated: June 7, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)